Laser, Ophthalmic

Product Code: HQF

Ophthalmic Medical Laser Products

Definition: Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Co

Applicable Standards: Laser Products. [1040.10] Specific Purpose Laser Products. [1040.11]

Code of Federal Regulations: 886.4390


Radiation TypeOptical
Radition SafetyProduct
Annual ReportsYes

Products Classified as HQF

4295Laser, OphthalmicOphthalmic Laser.

Total Product Life Cycle (TPLC) Devices

4295Laser, OphthalmicOphthalmic Laser.

FDA Consensus Standards

Laser, Ophthalmic [32410]21 CFR §886.4390 🔎
Laser, Ophthalmic [29877]21 CFR §886.4390 🔎
Laser, Ophthalmic [29297]21 CFR §886.4390 🔎

Pre-market Approvals for HQF

P990078HYPERION LTK SYSTEMSUNRISE TECHNOLOGIES, INC.

Pre-market Notifications for HQF

K223132Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm And 577 Nm Models)Iridex Corporation
K222395Tango Neo, Tango Reflex Neo, Ultra Q Reflex NeoEllex Medical Pty Ltd
K222157ECHO PhotocoagulatorNorlase
K220877Selecta Duet LED, Digital Duet, Selecta LED Trio, Digital Trio Laser SystemsLumenis Be, Inc.
K220430CapsuloQuantel Medical
K213592Iridex 810 LaserIridex Corporation
K212630Tango, Tango Reflex, Ultra Q, Ultra Q Reflex, SoloEllex Medical Pty Ltd
K202760Iridex 810 LaserIridex Corporation
K201502Vitra 810Quantel Medical
K192045Ophthalmic Yag Laser System YC-200Nidek Co., Ltd.
K190448LightLas Pattern Scanning System - TruScan ProLight-Med(USA), INC.
K190083Leaf PhotocoagulatorNorlase ApS
K181682VISULAS GreenCarl Zeiss Meditec AG
K180402PSLT With PASCAL Synthesis, PSLT With PASCAL Synthesis TwinStarTopcon Medical Laser Systems, Inc.
K171488PSLT For PASCAL StreamlineTopcon Medical Laser Systems, Inc.

Global Unique Device Identification Database

00380657529872Laser, ophthalmic
10380657517098Laser, ophthalmic
10380657517081Laser, ophthalmic
10380657515926Laser, ophthalmic
10380657515889Laser, ophthalmic
00380657511952Laser, ophthalmic
00380657511907Laser, ophthalmic
00380657510511Laser, ophthalmic
10380657509918Laser, ophthalmic
10380657509802Laser, ophthalmic
00380655011010Laser, ophthalmic
00380655002018Laser, ophthalmic
10380650104196Laser, ophthalmic
10380650102031Laser, ophthalmic
10632307002158Laser, ophthalmic

Maude Adverse Events

ZIEMER FEMTO LDVSIE AG, SURGICAL INSTRUMENT ENGINEERING2020-03-25
ZIEMER FEMTO LDVSIE AG, SURGICAL INSTRUMENT ENGINEERING2020-03-25
ZIEMER FEMTO LDVSIE AG, SURGICAL INSTRUMENT ENGINEERING2020-03-25
2020-03-23
TANGO RELLEX MEDICAL PTY LTD2020-03-13
PUREPOINT LASERALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER2020-03-10
PUREPOINT LASERALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER2020-03-10
PUREPOINT LASERALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER2020-03-10
PUREPOINT LASERALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER2020-03-03
PUREPOINT LASERALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER2020-03-03
PUREPOINT LASERALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER2020-03-03
DIRECTIONAL LASER PROBE WITH DORC CONNECTOR (25 GAUGE / 0.5 MM)D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER (INTERNA2020-03-03
VISULAS GREENCARL ZEISS MEDITEC AG (JENA)2020-03-02
PUREPOINT LASERALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER2020-03-02
PUREPOINT LASERALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER2020-02-27
PUREPOINT LASERALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER2020-02-21
PUREPOINT LASERALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER2020-02-11
TANGOELLEX MEDICAL PTY LTD2020-01-30
PUREPOINT LASERALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER2020-01-16
FEMTOSIE AG, SURGICAL INSTRUMENT ENGINEERING2020-01-16
PUREPOINT LASERALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER2020-01-13
PUREPOINT LASERALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER2020-01-03
EVAPHACOEMULSIFICATION/VITRECTOMY SYSTEMD.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER (INTERNA2019-11-22
PUREPOINT LASERALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER2019-10-17
PUREPOINT LASERALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER2019-10-14
PUREPOINT LASERALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER2019-10-07
PUREPOINT LASERALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER2019-10-07
PUREPOINT LASERALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER2019-09-24
PUREPOINT LASERALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER2019-09-19
PUREPOINT LASERALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER2019-09-16
PUREPOINT LASERALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER2019-09-16
PUREPOINT LASERALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER2019-09-13
PUREPOINT LASERALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER2019-09-10
PUREPOINT LASERALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER2019-09-03
TANGO REFLEXELLEX MEDICAL PTY LTD2019-09-03
PUREPOINT LASERALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER2019-08-27
PUREPOINT LASERALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER2019-08-20
PUREPOINT LASERALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER2019-08-13
PUREPOINT LASERALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER2019-07-24
PUREPOINT LASERALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER2019-07-23
PUREPOINT LASERALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER2019-07-16
ULTRA Q REFLEXELLEX MEDICAL PTY LTD2019-07-03
PUREPOINT LASERALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER2019-06-19
25G FLEXIBLE TIP LASER PROBEALCON RESEARCH, LLC (FORMERLY KNOWN AS ALCON RESEARCH LTD.)2019-06-17
PUREPOINT LASERALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER2019-06-17
PUREPOINT LASERALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER2019-06-11
PUREPOINT LASERALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER2019-06-04
PUREPOINT LASERALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER2019-05-30
PUREPOINT LASERALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER2019-05-29
PUREPOINT LASERALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER2019-05-23

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